Cost-effectiveness of EndWarts® FREEZE - an Alternative Home Cryotherapy Device for Wart Treatment

Mahidol University22 enrolled

Overview

This study aimed to study cost-effectiveness of EndWarts® FREEZE for wart treatment, compared to conventional liquid nitrogen cryotherapy

Cutaneous warts, caused by Human papilloma virus (HPV), are common skin disease. The prevalence reported in primary school children are 2-20%, and even higher in adults. Non-intact skin are prone to the infection, with all parts of the body can be affected. Even warts are not malignant, they can cause lack of confidence or affected patients' quality of life. Nowadays there are many treatment methods for warts, such as topical application with salicylic acid and electrical cauterization. Cryotherapy with liquid nitrogen has been the therapy of choice due to its clinical effectiveness, which reported for 6-65%. Treatment mechanism in cryotherapy relies on in-depth freezing of infected keratocyte. EndWarts® FREEZE is alternative home treatment cryotherapy device containing nitrous oxide. Recent clinical study found that it delivers significant result with good tolerability, and is user friendly. As for our knowledge, no study has been reported about cost-effectiveness of this device, so this study was designed to demonstrate the efficacy of this product in cutaneous warts.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cryotherapy Effect Warts

Interventions

EndWarts® FREEZEDEVICE

EndWarts® FREEZE is an alternative home cryotherapy device. Patients don't have to go to the hospital to receive treatment for their wart.

Liquid nitrogenDEVICE

Liquid nitrogen is a conventional cryotherapy treatment for cutaneous wart performed by physician at the hospital.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of plantar or common wart at Department of Dermatology, Siriraj hospital Exclusion Criteria: * Patient with more than 5 warts or wart more than 1 cm in diameter * Wart at face, genitalia, scalp, joint * Pregnancy or breastfeeding patient * Wart with wound/irritation or local infection * Diabetes mellitus patients or patients with coagulopathies or cryoglobulinemia * Immunocompromised host or on immunosuppressive drug * Received any treatment in previous 3 months before inclusion

Locations (1)

Department of Dermatology, Siriraj Hospital Mahidol University

Bangkok Noi, Bangkok, Thailand

Outcomes

Primary Outcomes

Cost-effectiveness of EndWarts® FREEZE

Evaluate cost-effectiveness of EndWarts® FREEZE for wart treatment compared with conventional liquid nitrogen therapy. Transportation fee to the hospital, medical and doctor fee are recorded to sum up the costs of treatment at every visit. Every patient is also required to have his/her wart examined by the same physician at each visit with the use of dermoscope to evaluate the result of wart treatment (worse, the same, partial response, complete response). Moreover, wart size is measured for its diameter and height, then photographed at each visit to recorded the change after treatment. Cure rates will be shown according to type of intervention received, with the use of chi-square test.

Time frame: 12 weeks

Secondary Outcomes

Compared Dermatology quality of life index before and after treatment

Compared patient's Dermatology quality of life index (DLQI) between treatment of EndWarts® FREEZE and liquid nitrogen. DLQI is recorded before the treatment start and after 12-week treatment (or before 12 week if the patient's wart is cured completely). Change in DLQI will be shown with descriptive statistics.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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